Kigabeq

Neurology· 137 cited findings· 1 source document

Company: Orphelia Pharma

What the regulatory reviews say

Kigabeq (Vigabatrin ORPHELIA Pharma 500 mg soluble tablets) is a drug indicated for the treatment of infantile spasms and resistant partial epilepsy in children. Its efficacy was evaluated against Sabril 500 mg granules for oral solution. In a bioequivalence study, the Geometric Mean Ratio Test/Ref for Cmax was 103.06% (90% Confidence Interval: 96.96 - 109.54%) and for AUC0-t was 100.14% (90% Confidence Interval: 96.95 - 103.43%).

Clinical efficacy data for Vigabatrin showed a seizure frequency reduction of >= 50% in 33.3% of patients with partial seizures and 30.6% in patients with primary generalized seizures. Complete resolution of seizures was observed in 6 patients with partial seizures. The initial recommended dose for infantile spasms is 50 mg/kg/day, with a maximum recommended dose of 150 mg/kg/day. For resistant partial epilepsy in children, the recommended starting dose is 40 mg/kg/day.

Safety findings indicate no new particular safety issues when comparing Kigabeq to Sabril. The most frequent adverse event reported was headache. A total of 65 adverse events were reported, with 2 considered related to the study treatment. The Marketing Authorisation Application was submitted on 29 May 2017, and a CHMP positive opinion was issued on 26 July 2018.

Key figures — cited to the source page

Geometric Mean Ratio Test/Ref for Cmax	103.06	Orphelia S A S — Kigabeq EMA EPAR public assessment report (, p.29
90% Confidence Interval for Cmax	96.96 - 109.54	Orphelia S A S — Kigabeq EMA EPAR public assessment report (, p.29
Geometric Mean Ratio Test/Ref for AUC0-t	100.14	Orphelia S A S — Kigabeq EMA EPAR public assessment report (, p.29
Vigabatrin seizure frequency reduction >= 50% (partial seizures)	33.3	Orphelia S A S — Kigabeq EMA EPAR public assessment report (, p.33
Vigabatrin seizure frequency reduction >= 50% (primary generalized seizures)	30.6	Orphelia S A S — Kigabeq EMA EPAR public assessment report (, p.33
Most frequent AE	headache	Orphelia S A S — Kigabeq EMA EPAR public assessment report (, p.29
Adverse events considered related to study treatment	2	Orphelia S A S — Kigabeq EMA EPAR public assessment report (, p.50
CHMP positive opinion date	26 July 2018	Orphelia S A S — Kigabeq EMA EPAR public assessment report (, p.9

Source documents

Orphelia S A S — Kigabeq EMA EPAR public assessment report (EMEA/H/C/004534, 2018) (2018)

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.